Citing sterility concerns, Hospira, a subsidiary of pharma giant Pfizer, is voluntarily recalling vials used to inject sodium bicarbonate during surgery and in critical events. The nationwide recall adds to the ongoing shortage of the drug.
The voluntary recall was announced on the FDA’s website and covers sodium bicarbonate and succinylcholine chloride vials after microbial growth was detected during a routine simulation of the manufacturing process. While no batches of distributed product were identified as containing microorganisms, the drugmaker took the step as a precaution.
As part of the action, 42 lots of sodium bicarbonate vials were recalled along with five lots of succinylcholine chloride. Hospira said it is unaware of any reports of adverse events associated with the drug.
In a separate statement, the regulatory agency said it is aware of the ongoing shortage situation affecting several injectable drugs manufactured by Hospira. Those include sodium bicarbonate injection (vials and syringes), dextrose 50% injection (vials and syringes), as well as emergency syringes of other drugs, including epinephrine, calcium chloride and atropine sulfate.
According to Pfizer, the shortages have resulted from a mix of manufacturing issues, distribution and third-party delays.
“The agency is working to relieve these shortages through a variety of measures, including finding alternative manufacturers of these drug products,” the agency said in a statement. “FDA continues to explore all available options, which may include expediting review of applications or other submissions, or considering temporary regulatory flexibility for alternative sources.”
To help ease the shortage, the FDA also said it is extending use dates on certain lots of emergency syringes based on stability data provided by Pfizer that has been reviewed by the agency.
Pfizer is the central manufacturer of sodium bicarbonate. It acquired Hospira in 2015 as part of a $15 billion buyout.